Intracorporeal transillumination of tissue using led array

ABSTRACT

A device which illuminates internal tissue and organs of a patient is described. The illumination member includes an array of light-emitting diodes (“LEDs”). The arrangement of the array depends on the configuration of the device and the procedure for which the device is being used. In all cases, the illumination member is used to illuminate relevant organs or structures in the body in order to increase visibility during surgical procedures. The LED array reduces the potential for inadvertent injury to internal structures for procedures located throughout the body. These procedures include those involving the reproductive organs of males and females, gastric and bariatrics, and other structures in the abdomen.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/684,708, filed Aug. 23, 2017, now allowed, which is a continuation ofU.S. application Ser. No. 14/295,550, filed Jun. 4, 2014, now U.S. Pat.No. 9,743,955, which claims the benefit of U.S. Provisional PatentApplication No. 61/830,696, filed Jun. 4, 2013, each of which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

This invention relates to the field of devices fabricated forintracorporeal treatment of the human body. More specifically, theinvention comprises a device which can illuminate certain tissue withina patient's body primarily by passing light through those tissues. Theinvention assists surgical operations in many ways, including clearlydefining a location for an incision. The device, which can take manyforms, uses embedded LED lights in order to illuminate the relevanttissue, organ or other structures.

BACKGROUND

The human body consists of a series of internal organs Like the rest ofthe human body, internal organs are affected by disease, the inabilityto function properly, as well as other complications. In theseinstances, it may become important to investigate, or in the mostextreme case, remove the problematic organ(s) or portions thereof. Adoctor can investigate the state of a person's organs or tissue usingendoscopy or laparoscopy. The term “endoscope” refers generally to avisualization tool—now typically a small digital camera—that may beinserted into a patient's body through an existing orifice or a smallincision. Similar visualization devices have differing names dependingupon their region of intended use. For example, a “laparoscope” is avisualization device that is intended for use in the patient's abdomen.Using an appropriate “scope” tissue that needs to be removed can beidentified and excised using other surgical tools passed into the samearea. Laparoscopy continues to become more popular as advancements aremade in this field. If laparoscopy is an option for a patient's surgicalprocedure, then the benefits can be enormous compared to laparotomy.These advantages include reducing post-operative pain, shorteninghospital stays, and reducing recovery times. Although laparoscopy is notalways an option for surgery, these advantages have led to more surgicalprocedures that use laparoscopy or computer-aided laparoscopy.

In the case of laparoscopy and laparotomy, it is extremely important forthe surgeon to have the clearest view possible. Of course, in the caseof laparotomy this is less of a problem since the patient has a largeincision that allows the surgeon to see into the patient's body usingambient light from the operating room and fixed lights shining onto theoperation region. However, laparoscopic surgery is accomplished usingonly a few small incisions in the patient's body with all the structureshaving to be viewed through the small “scope.”

Although laparoscopic surgery is less invasive than laparotomy, onecommonly cited drawback is a lack of visibility of the operating area asit relates to visualizing hidden critical structures and the limitedtactile feedback or the lack thereof altogether in robotic surgeryapplications. In laparoscopic surgery, this lack of visibility andtactile feedback can potentially lead to injury of vital structuresincluding the ureters, bladder, major vessels, nerves as well as anyother structures or organs in the relevant region of surgery (thisdepends on location of surgery). It would appear, then, that increasedvisibility would reduce the risk of injury during laparoscopic surgery.

One of many procedures that benefit from the use of laparoscopic surgeryis a hysterectomy. A hysterectomy is the procedure in which a patient'suterus is surgically removed. There are several types of hysterectomiesthat can be performed. For example, a radical hysterectomy is thecomplete removal of the uterus, cervix, upper vagina, and parametrium.This type of hysterectomy is commonly used for the treatment of cancer.A total hysterectomy is the complete removal of the uterus and cervix,with or without oophorectomy (removal of the ovaries). A subtotalhysterectomy is the removal of the uterus, leaving the cervix in situ.

A common device used in laparoscopic hysterectomy is a uterinemanipulator. A uterine manipulator is used to delineate the proper planeof dissection for colpotomy at the cervicovaginal junction (which isequipped with a colpotomy cup). In the event of a radical hysterectomyor a procedure involving a patient having cancer, a sponge stick is thepreferred tool—due to the absence of a stem entering the uterus. Whilean intrauterine stem is helpful for retraction of the uterus, the riskof inadvertent uterine perforation transabdominally is increased, whichcan cause upstaging of the cancer due to cancer cells spilling into theabdomen. This must be avoided at all costs.

A hysterectomy is a procedure which is commonly performed using alaparoscopic or robotically assisted laparoscopic technique. Therefore,what is needed in this particular example is a device that increases thevisibility of the location at which to cut and/or cauterize the tissuein order to remove the patient's uterus more safely and effectively.However, more generally, what is needed is a device that increases thevisibility of the location within the body at which the surgicalprocedure is taking place. Oftentimes the objective is to cut orcauterize tissue, but the objective can include any number ofprocedures—such as drawing fluid, locating a structure, stapling tissue,or simply maneuvering an organ or other structure. The present inventionachieves this objective, as well as others that are explained in thefollowing description.

BRIEF SUMMARY OF THE INVENTION

The present invention comprises a device which illuminates internaltissue and organs of a patient. The device is available in many forms.The form of the device is dependent on the procedure for which thedevice is used. Each device includes an array of light-emitting diodes(“LEDs”). The arrangement of the array also depends on the configurationof the device and the procedure for which the device is being used. Inthe case of the example given in the preceding text, a hysterectomy, theLED array is positioned in the form of a ring embedded within acolpotomy cup. This allows the LED array to transilluminate the tissuesurrounding the cervix (illuminate the critical area by actually passinglight through a portion of the tissue). When performing a laparoscopichysterectomy a surgeon inserts a laparoscope and a cutting orcauterization device through ports in a patient's abdomen. At the sametime, a uterine manipulator is often passed through the vagina and intothe uterus (often with a “cup” encircling the cervix). Thus, the tissueof the patient is being physically manipulated from one side of anenclosed volume (inside the vagina/uterus) while the actual incision isbeing performed on the opposite side of this volume (inside the abdomenbut outside the uterus.

In the present invention, an array of powerful LED lights is provided onthe end of a specially shaped distal end of an elongate member. As anexample, in the case of a hysterectomy, the distal end may assume theform of a colpotomy ring with the LED array being disposed about thecircumference of the ring. When the LED lights are illuminated thesurgeon is able to easily and efficiently locate the colpotomy ringbehind the relevant tissue by way of transillumination. The LED array islocated inside the vagina/cervix and the surgeon can see the light fromthe LED's passing through the wall of the cervix. Thus, the LED arraydevice allows the surgeon to make an incision at the proper location tobest remove the uterus safely and effectively.

Although the example provided is that of a hysterectomy with an LEDarray in the shape of a ring, the LED array of the present invention maybe applied to many procedures and devices. The LED array reduces thepotential for inadvertent injury to internal structures for procedureslocated throughout the body. These procedures include those involvingthe reproductive organs of males and females, gastric and bariatrics,and other structures in the abdomen.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a perspective view, showing a preferred embodiment of thepresent invention for a generic surgical procedure.

FIG. 2 is a perspective view, showing a prior art uterine manipulator.

FIG. 3 is a schematic view, showing a prior art device in use.

FIG. 4 is a perspective view, showing a preferred embodiment of thepresent invention.

FIG. 5 is a schematic view, showing the embodiment of FIG. 4 in useduring a hysterectomy procedure.

FIG. 6 is a perspective view, showing an alternate embodiment of thepresent invention.

FIG. 7 is a perspective view, showing another alternate embodiment ofthe present invention.

FIG. 8 is a schematic view, showing the embodiment of FIG. 7 in use.

FIG. 9 is a perspective view, showing another alternate embodiment ofthe present invention.

FIG. 10 is a schematic view showing the embodiment of FIG. 9 in use.

FIG. 11 is a perspective view, showing yet another alternate embodimentof the present invention.

FIG. 12 is a schematic view, showing the embodiment of FIG. 11 in use.

FIG. 13 is perspective view, showing an alternate embodiment of thepresent invention.

REFERENCE NUMERALS IN THE DRAWINGS 10 illumination member 12 memberhandle 13 LED mounting surface 14 elongate member 16 distal end 18 LEDarray 20 uterine manipulator 22 colpotomy ring 24 intrauterine balloon26 control handle 28 elongate member 30 positioning member 32 cuttingdevice 34 vaginal canal 36 cervix 38 body of patient 40 tissue 42 LED 44LED power cord 46 balloon 48 LED adjustment knob 50 uterus 52 suctionport 53 irrigation port 54 esophagus 56 stomach 58 antrum 59 suctionport 60 bladder 62 penis 64 urethra

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a device which illuminates a region ofinterest within a patient's body during surgery or other medicalprocedures. FIG. 1 shows a relatively simple embodiment that includesthe preferred features. Illumination member 10 varies with eachapplication for various procedures. Here, illumination member 10includes member handle 12, LED mounting surface 13, elongate member 14,distal end 16, and light emitting diode (“LED”) array 18.

In general, distal end 16 is inserted into the patient's body. Elongatemember 14 creates distance between the operator and the cavity in whichillumination member 10 is inserted. Although elongate member 14 is shownas a cylinder with a linear axis in space, it may have a curved axis inspace. It may also include features allowing it to be bent in variousways to conform to the relevant anatomy. In addition, LED array 18 isshown as two linear arrays, but LED array 18 can take many forms such asa curved array, a circular array, or any other planar shape including asingular LED. Most of these embodiments will be demonstrated in thefollowing examples of alternate embodiments of the present invention.

One of the primary applications for illumination member 10 is that of ahysterectomy, or the removal of a uterus and/or other reproductiveorgans. In order to aid the reader's understanding, it is helpful toconsider some prior art instruments used in this procedure. FIG. 2illustrates a prior art uterine manipulator 20 in conjunction with acolpotomy ring 22 and an intrauterine balloon 24. This type of prior artdevice is typically used in a laparoscopic hysterectomy. As illustrated,uterine manipulator 20 includes a control handle 26 and elongate member28, which attaches to colpotomy ring 22, positioning member 30 andpneumo-occluder balloon 24. In use, the colpotomy ring 22 is insertedinto the vaginal canal of the patient until the colpotomy ring 22reaches the vaginal fornices and cervix. The intra-uterine balloon 24 isdirected into the uterus of the patient and is expanded inside of theuterus in order to secure the device. A series of ports are insertedthrough the abdomen of the patient which allows accommodation of thelaparoscope and other suture or specialized laparoscopic instrumentssuch as cutting/cauterizing devices, specimen retrieval bag, Endo Stitchsuture-assist device or a tissue morcellator.

The reader will appreciate that a variety of laparoscope instruments canbe used to perform a hysterectomy. Thus, the application should not belimited by the use of any specific instruments. As illustrated in FIG.3, the cutting device 32 enters the patient's body such that therelevant tissue to be cut or cauterized is between the cutting device 32and the colpotomy ring 22. The viewing device is typically inserted nextto cutting device 32. Thus, the viewing device cannot directly see thelocation of the colpotomy ring other than by noting the bulge it createsin the cervical tissue. The surgeon may therefore have a difficult timeidentifying the exact location at which the tissue should be cut orcauterized.

As illustrated, uterine manipulator 20 is fully inserted into thevaginal canal 34. Intrauterine balloon 24 is inflated in order to keeputerine manipulator 20 in position. Colpotomy ring 22 is positionedwithin the vaginal fornices at the opening of the cervix 36. During theoperation a cutting device 32 enters the patient's body 38 through aport (not shown). The surgeon must position cutting device 32 such thatas the cut through the tissue 40 is made, the cuff of the colpotomy ring22 is on the opposing side.

FIG. 4 shows an embodiment of the present invention used for this samehysterectomy procedure. Illumination member 10 replaces uterinemanipulator 20 and its associated colpotomy ring. In a preferredembodiment, illumination member 10 includes member handle 12, elongatemember 14, distal end 16, and LED array 18 (as discussed in thepreceding text). In addition to the primary elements, this embodiment ofillumination member 10 includes colpotomy ring 22, intrauterine balloon24, and positioning member 30. The reader will note that an importantdifference between prior art uterine manipulator 20 and this embodimentof illumination member 10 is the addition of LED array 18. Also,illumination member 10 preferably includes LED power cord 44 (which mayrun internally within elongate member 14). Preferably, LED power cord 44leads to a power switch device (not shown). In a preferred embodiment,the switch has multiple functions, including the capability of switchingthe LEDs ON/OFF, dimming and brightening, flashing, etc.

FIG. 5 illustrates the embodiment of FIG. 4 being used in a laparoscopicsurgery. As illustrated, illumination member 10 is fully inserted intothe vaginal canal 34. Colpotomy ring 22 is positioned within the vaginalfornices at the opening of the cervix 36. LED array 18 is located at theupper cuff of the colpotomy ring 22. During the operation a cuttingdevice 32 enters the patient's body 38 through a port (not shown). Thesurgeon must position cutting device 32 such that as the cut through thetissue 40 is made, the cuff of the colpotomy ring 22 is on the opposingside.

The present illumination member 10 allows the surgeon to effectively seethrough the tissue to identify the exact location of colpotomy ring 22.When the LED's are switched on, they shine through the tissue walldefining the cervix. The surgeon, who is looking through the laparoscopeon the opposite side of the tissue wall, can actually see the LED's andthereby precisely visualize the location of the colpotomy ring. Asdiscussed above, LED lights 42 can be brightened if tissue 40 is thickand difficult to see through or can be selectively dimmed as the tissueis cut so that the light is not too bright.

This procedure illustrates a general case of the invention's use. It ismost effective in illuminating a tissue wall that separates a firstvolume within a patient's body from a second volume. In the case oflaparoscopic surgery of FIG. 5, the first volume is contained within thevagina/cervix/uterus. Access to this volume is obtained through a firstopening in the patient's body (the vagina). Illumination member 10 isinserted through the vagina and thereby gains access to this firstvolume.

The second volume in this scenario is the volume within the abdominalcavity that lies outside the vagina/cervix/uterus. Access to this secondvolume is obtained via an incision. The LED array is then placed againstthe tissue wall and the LED's are illuminated. The light from the LED'sshines through the tissue wall and becomes visible in the second volume.

Illumination of the relevant tissue in the first volume of the patientallows the surgeon to identify the location of that tissue vialaparoscope inserted into the second volume of the patient. In the caseof a hysterectomy, that tissue is to be cut in order to remove thepatient's uterus. However, other surgical action can be taken. Surgicalaction can take many forms—some examples include cutting, grasping,cauterizing, scraping, stitching, puncturing, securing, strengthening,viewing, reshaping, stapling, or removing. The reader will note thatthis is not meant to be an exhaustive list of all the surgical actionsthat can be accomplished, but rather some examples given to demonstratethe large number of surgical actions. Thus, the scope of the presentinvention should not be limited to any single surgical action.

The reader will also note that tissue 40 creates a wall of tissuebetween the first and second volumes as described in the preceding text.In the case of the hysterectomy, that wall of tissue is the region wheresurgical action is required. Transillumination of the wall of tissueindicates to the surgeon which region to cut. In general, a wall oftissue may separate the first volume and the second volume. It should benoted, however, that surgical action does not necessarily occur at thewall of tissue. In fact, the wall of tissue may simply provide thebarrier between the two volumes.

Oftentimes, especially in the case of cancer, it is dangerous to insertpositioning member 30 and intra-uterine balloon 46 into the uterus. Inthe case of accidental perforation of the uterus, cancerous cells couldspill into the abdomen. Typically, a doctor will use ring forcepsgrasping a sponge instead of uterine manipulator 20 in order to avoidentering the uterus. This technique allows for very limited manipulationof the tissue while limiting the risk of uterine perforation by enteringthe uterus. FIG. 6 shows an alternate embodiment of illumination member10 that is intended to deal with this situation. The reader will noticethat the embodiment illustrated is similar to uterine manipulator 20.Illumination member 10 includes member handle 12 and colpotomy ring 22located on distal end 16. This particular embodiment of illuminationmember 10 allows the surgeon to transilluminate the relevant tissuesurrounding the cervix (as discussed in the preceding text) without anypieces entering the uterus. Thus, even in the case of cancer in theuterus or other complications, LED array 18 can be utilized in order tomore readily and effectively perform a hysterectomy.

Still another embodiment of the illumination member 10 is shown in FIG.7. The reader will note that the distal end 16 of illumination member 10is enlarged compared to the previous embodiment. As illustrated, LEDarray 18 can take the form of a ring or LEDs 42 can span distal end 16axially. The organization of LEDs 42 on distal end 16 is dependent onthe application of illumination member 10. Thus, the reader should notlimit the scope of the present invention based on the form or placementof LED array 18.

The embodiment of illumination member 10 in FIG. 7 is used as a vaginalplane delineation device. The device is used as a transvaginalretraction and positioning device for vaginal vault dissection during asacrocolpopexy surgical procedure. FIG. 8 shows the device in use. LEDarray 18 allows for transillumination of the vaginal vault in order tobetter delineate the vesicovaginal plane and the rectovaginal plane.

FIG. 9 shows yet another alternate embodiment of illumination member 10.FIG. 10 illustrates the application of this particular embodiment.Preferably, the embodiment of illumination member 10 in FIG. 9 is usedin gastric and bariatric surgical procedures in order to provide visibleand tactile delineation of the antrum of the stomach. Illumination ofthis region using LED array 18 allows a surgeon to easily identify theplacement of the distal end 16 of the device 10. In addition,illumination member 10 preferably includes components similar to thoseof a gastric calibration tube such as suction port 52. In addition,illumination member preferably includes irrigation port 53. Suction port52 and irrigation port 53 allow the surgeon to add and remove liquidduring a procedure in the gastric channel.

This particular embodiment of the present invention is inserted into thepatient's esophagus 54, through stomach 56 and into antrum 58. Thereader will note that this particular embodiment is preferably madeflexible in order to navigate the gastric channel. It may also includeguiding wires that a surgeon can employ to manipulate the curvature anddeflection direction of the device. In a preferred embodiment, elongatemember 14 is fabricated from a soft, hollow conduit such as silicone.LED array 18 is preferably located at the very tip of distal end 16.Preferably, member handle 12 includes a check valve mated with a syringe(not shown) which is used to fill balloon 46.

FIGS. 11 and 12 illustrate the application of illumination member 10 asa Foley catheter. This embodiment includes the all of the components ofa typical prior art Foley catheter with the addition of LED array 18. Inaddition to the management of urination, a catheter is also used toidentify the bladder during surgical procedures. Preferably, elongatemember 14 is fabricated from a flexible, hollow material. The preferredembodiment of the present invention includes two hollow conduits—one isused for the drainage of urine and the other is to inflate balloon 46.LED array is preferably embedded into balloon 46, but can also beattached at the tip of distal end 16 as illustrated.

As illustrated, illumination member 10 is inserted into the urethra 64,spanning the length of penis 62 and into bladder 60. By illuminating LEDarray 18 within bladder 60, surgeons working in the abdominal cavityproximate the bladder can positively identify the location of thebladder, thereby avoiding accidental injury to the bladder andsurrounding structures.

A circular stapler spike is used to perform anastomoses in a patient.The spike portion is coupled with an anvil in the alimentary canal forthe creation of end-to-end, end-to-side, and side-to-side anastomoses.FIG. 13 shows illumination member 10 in the form of the spike used foranastomoses. LED array 18 allows illumination of the region of interestinside the patient during a surgical procedure. Preferably, illuminationmember 10 is a disposable spike which replaces the original spike on acircular stapler device. However, illumination member 10 can also takethe form of a sheath that fits over the original spike on the staplerdevice. In either form, the spike increase visibility for the surgeon inorder to perform anastomoses.

Returning to the embodiment of FIG. 7, some preferred features of theinvention will be discussed in more detail. The reader will note thatthe distal end of the illumination member assumes the form of a shapedsurface (in this case a cylinder with a smoothly filleted leading edge).It is preferable to contour this surface so that it rests smoothlyagainst the anatomy it is intended to contact. The portion of thissurface that contains the LED array is known as an “array mountingsurface.” This surface is shown generally in FIG. 1, but it ispreferably included with each embodiment. This surface is preferablyshaped to place the LED's in position against the relevant tissue wall.Of course, in some cases a simple shape will suffice.

Each embodiment of the present invention preferably includes a powersource and controller for the LED array. Preferably, the power source isa lithium-ion rechargeable battery. However, in the case where theillumination member is disposable, along with the circuitry, a lessexpensive power supply can be used—such as AA batteries. The controllerfor the LED array can be as simple as a power ON/OFF switch. In thepreferred embodiment of illumination member, the LED controller hasdimming functionality. In some embodiments, the LED power source andcontroller are integral to the member handle. This is the preferredconfiguration, but may not be possible in all embodiments.

LED lights are particularly beneficial when applied to devices thatenter the body or contact the tissue of a patient and in use during alaparoscopic surgery because of the natural properties of a LED light,namely, that LED lights are small in area and can achieve highbrightness while remaining cool to the touch. Further, LED lights arepowerful, have lower energy consumption and have a longer lifetime.Thus, it is important that the present ring device includelight-emitting diodes lights.

The preceding description contains significant detail regarding novelaspects of the present invention. It should not be construed, however,as limiting the scope of the invention but rather as providingillustrations of the preferred embodiments of the invention. Thus, thescope of the invention should be fixed by the following claims, ratherthan by examples given.

It is claimed:
 1. A device for in vivo transillumination of a tissue,comprising: an elongate member with a distal end and a proximal end; ahandle on the proximal end; a shaped surface disposed on the distal endof the elongate member in a fixed position, the shaped surfacecomprising an array of light emitting diodes (LEDs) to illuminate afirst side of an in vivo tissue wall that separates a first volumewithin a human body from a second volume, the shaped surface beinglocatable from a second, opposing side of the in vivo tissue wall whenthe array of LEDs illuminate the first side of the in vivo tissue wall;a positioning member comprising a lumen and an inflatable balloonpositioned on a distal end of the positioning member, wherein a portionof the positioning member extends along a pathway formed in the elongatemember; and the lumen forms a hollow conduit configured to inflate theinflatable balloon; a power source; and a controller for the array ofLEDs.
 2. The device of claim 1, wherein the elongate member is acylinder having a smooth outer surface, wherein the elongate member isselected from a flexible elongate member and a rigid elongate member. 3.The device of claim 1, wherein the shaped surface is selected from acylindrical shaped surface, a spherical shaped surface, a planar shapedsurface and a curved surface of a cone.
 4. The device of claim 1,further comprising a suction port, an irrigation port, or both.
 5. Thedevice of claim 1, wherein the power source is a battery.
 6. The deviceof claim 1, wherein the controller is an on/off switch.
 7. The device ofclaim 1, wherein the controller has a variable illumination intensityadjustment feature, a variable illumination color adjustment feature, ora variable illumination pulsing feature.
 8. The device of claim 1,wherein the elongate member comprises two hollow conduits.
 9. The deviceof claim 1, wherein the elongate member is disposable.
 10. The device ofclaim 1, wherein the device is disposable.
 11. A method for in vivotransillumination of a tissue, comprising: providing a device of claim1, whereby when the device is inserted into a first volume of a humanbody separated from a second volume by a tissue wall having a first sideand a second, opposing side, the shaped surface when in contact with thefirst side of the tissue wall locatable on the opposing side of thetissue wall when the array of LEDs is illuminated.
 12. The method ofclaim 11, whereby said shaped surface contacts the tissue wall on thefirst side when the device is inserted into the first volume of a humanbody.
 13. The method of claim 11, wherein said first volume comprises apatient's uterus and said second volume comprises a patient's abdomen.14. The method of claim 11, wherein the tissue separating the firstvolume and the second volume is the cervicovaginal junction.
 15. Themethod of claim 14, wherein the shaped surface is a cylindrical surface.16. The method of claim 11, wherein the first volume includes apatient's vaginal canal and the second volume includes a patient'sabdomen.
 17. The method of claim 16, wherein the tissue separating thefirst volume and the second volume is a vaginal wall.
 18. The method ofclaim 17, wherein the shaped surface is a cylindrical or annular. 19.The method of claim 11, wherein the first volume includes a patient'sgastrointestinal tract and the second volume includes a patient'sabdomen.